Clearance Summary
SURGICRAFT COPELAND DISPOSABLE received FDA 510(k) clearance under submission number K844608, sponsored by A.W. Showell (Surgicraft) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1985-05-01.
- Submission: K844608
- Applicant / Sponsor: A.W. Showell (Surgicraft) , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2675
- Decision date: 1985-05-01
Classification & Regulation
This clearance is catalogued under FDA product code HGP and 21 CFR 884.2675, within the Obstetrics/Gynecology review panel as a Class II device.